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SVP Global Biotherapeutic Quality - Seattle, WA United States

Employer
Just - Evotec Biologics
Location
Seattle, WA
Start date
Dec 5, 2023

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioForest

Just-Evotec Biologics is seeking an experienced and visionary SVP of Global Biotherapeutic Quality to join our executive leadership team. The SVP of Global Biotherapeutic Quality will be responsible for overseeing the quality management and compliance functions related to our biotherapeutic products across all global markets. This position will play a critical role in ensuring that our products meet or exceed regulatory requirements and industry standards while upholding our commitment to patient safety and product excellence.

Responsibilities

Quality Strategy and Leadership:

  • Develop and execute a comprehensive global quality strategy that aligns with the company's mission and objectives
  • Develop/Build a scalable quality organization to meet the corporate goals
  • Provide strategic leadership to the global quality organization, ensuring the team is equipped to meet current and future challenges
  • Foster a culture of quality and compliance throughout the organization

Regulatory Compliance:

  • Monitor and interpret global regulatory requirements related to biotherapeutic products
  • Ensure the company's compliance with all applicable regulations and standards, including, ISO, FDA, EMA, and other relevant agencies
  • Lead interactions with regulatory authorities and manage inspections and audits

Quality Systems and Processes:

  • Establish and maintain robust quality systems and processes that cover the entire product lifecycle, from development through commercialization
  • Continuously improve and optimize quality systems to enhance efficiency and effectiveness
  • Implement risk-based approaches to quality management

Product Quality Assurance:

  • Oversee the quality assurance and quality control functions to ensure the consistent production of safe and effective biotherapeutic products
  • Collaborate with R&D and Manufacturing teams to implement best practices for product quality
  • Drive a culture of continuous improvement in product quality and reliability

Quality Metrics and Reporting:

  • Define and monitor key performance indicators (KPIs) for quality and compliance
  • Provide regular reports and updates to the executive team and the board of directors on the state of quality within the organization

Talent Development and Team Building:

  • Recruit, develop, and retain top talent within the global quality organization
  • Foster a collaborative and high-performance culture within the team

Qualifications and Educational Requirements

  • A Bachelor's degree in a relevant scientific or engineering field; advanced degrees (e.g., M.S., Ph.D.) are a plus
  • Extensive experience (15+ years) in Quality and Regulatory Affairs within the biopharmaceutical or pharmaceutical industry
  • Proven track record of successfully leading global quality organizations and driving quality initiatives
  • In-depth knowledge of global regulatory requirements and quality standards for biotherapeutic products
  • Strong leadership and communication skills with the ability to influence and collaborate at all levels of the organization
  • Exceptional problem-solving and decision-making abilities
  • Experience in managing and leading quality during product development, manufacturing, and commercialization phases

The base pay range for this position at commencement of employment is expected to be $210,000 to $340,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

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